With Novartis' Piqray recently approved by the FDA for the treatment of PIK3CA-mutated, HR-positive, HER2-negative breast cancer, we are snap-polling oncologists about this therapeutic option for a second time (we ran this poll when data from the Phase III SOLAR-1 study were presented at last year's ESMO meeting).
Impressive clinical data suggests Piqray could become a blockbuster, though experts are concerned about what they perceive to be a lack of sufficient data from patients who have previously been treated with a drug from the widely used CDK4/6 inhibitor class. What do front-line oncologists think…?
Q. The FDA has approved Piqray (alpelisib) for use in combination with Faslodex (fulvestrant) for the treatment of HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. [European approval is pending]
In the Phase III SOLAR-1 study, the addition of Piqray to Faslodex cut the risk of death or disease progression by 35 percent, compared with Faslodex alone. Median progression-free survival was 11 months for Piqray/Faslodex versus 5.7 months for Faslodex alone. Overall response rate was 35.7 percent for Piqray/Faslodex versus 16.2 percent for Faslodex alone.
In terms of safety, the discontinuation rate due to adverse events was 5 percent for Piqray/Faslodex compared to 1 percent for Faslodex alone.
The most common all-grade adverse events were hyperglycaemia (64% vs. 10%), diarrhoea (58% vs. 16%), nausea (45% vs. 22%), decreased appetite (36% vs. 11%) and rash (36% vs. 6%). Of these, the most common grade 3/4 events were hyperglycaemia (37% vs. <1%), rash (10% vs. <1%), and diarrhoea (7% vs. <1%).
Based on these data, what is your overall opinion of Piqray as a new treatment option?
1 - Very poor
3 - Neutral
5 - Excellent
Q. Approximately what percentage of HR-positive, HER2-negative breast cancer patients you manage are currently treated with a CDK4/6 inhibitor such as palbociclib in the first or second-line setting?
Q. Of the 572 HR-positive, HER2-negative patients enrolled in the SOLAR-1 study, 6 percent had previously been treated with a CDK4/6 inhibitor such as palbociclib. How will this impact your future use of Piqray?
1 - Significantly reduce my future use
3 - Neutral impact
5 - Significantly increase my future use
Q. A companion diagnostic for detecting the PIK3CA mutation was simultaneously approved by the FDA; it is estimated that approximately 40 percent of patients with HR+/HER2- breast cancer have this mutation.
How quickly do you think adoption of PIK3CA testing will occur, based on the available data for Piqray?
1 - Very slowly
3 - Moderately
5 - Very quickly
Q. In what line of therapy do you ultimately expect to end up using Piqray most frequently based on its initial clinical data and label?
Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
As always, FirstWord would very much like to receive your feedback and suggestions.
Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at firstname.lastname@example.org.
Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls. However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.
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